At a Glance
- Tasks: Lead statistical strategies for clinical trials and regulatory submissions in a dynamic environment.
- Company: Join a leading biopharmaceutical company focused on innovative drug development.
- Benefits: Competitive salary, health benefits, flexible work options, and opportunities for professional growth.
- Other info: Collaborative culture with opportunities to engage with regulatory authorities.
- Why this job: Make a real impact in healthcare by shaping clinical development strategies.
- Qualifications: PhD or MS with extensive experience in drug development and statistical leadership.
The predicted salary is between 80000 - 100000 £ per year.
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program.
Responsibilities
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
- Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
- Influence and contribute to clinical development plans, collaborate with cross‑functional team for governance reviews.
- Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go‑No‑Go criteria and probability of technical success calculations.
- Provide for project‑wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
- Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
- Manage outsourcing operations or work with internal statistical programmers within the responsible program.
- Ensure timeliness and quality of deliverables by CRO/FSP.
- Support or lead improvement initiatives within the department, organization and/or pharma industry.
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programmes and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Qualifications
- PhD with 8 years of experience or MS with 11 years of experience in drug development.
- Experience providing statistical leadership at compound/indication level.
- Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full‑) clinical development strategy.
- Solid experience in applications of advanced statistical methodologies.
- Leading roles in regulatory submissions.
- Experience in interactions with major regulatory authorities preferred.
- Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred.
- Track record of innovation preferred.
Competencies
- Familiarity with regulatory guidance and interactions.
- Broad knowledge of clinical development and processes.
- Ability to collaboratively work and provide leadership in matrix environment.
- Strong interpersonal and communication skills (verbal and written in English).
- Good working knowledge of SAS and/or R.
- Expertise in a range of statistical methodologies.
- Demonstrated use of innovative / creative methodology for analysis of clinical data.
- Familiarity with relevant regulatory guidance documents.
- Expertise in CDISC, statistical programming, and/or data standards.
Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit CSL Accessibility Statement.
Associate Director, Biostatistics (2) in Maidenhead employer: CSL Plasma Inc.
As an Associate Director in Biostatistics, you will thrive in a dynamic and collaborative environment that prioritises innovation and excellence in clinical development. Our company offers robust employee growth opportunities, a supportive work culture, and the chance to lead impactful projects that shape the future of healthcare. Located in a vibrant area, we provide a unique blend of professional challenges and personal fulfilment, making us an exceptional employer for those seeking meaningful contributions in the biostatistics field.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Biostatistics (2) in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methodologies and regulatory knowledge. Be ready to discuss how you've applied these in past projects, especially in clinical trials. We want to see your expertise shine!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Check out our website for openings that match your skills in biostatistics and make sure to tailor your approach to each one.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Share any additional insights or thoughts you had post-interview to show your enthusiasm for the role.
We think you need these skills to ace Associate Director, Biostatistics (2) in Maidenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that match the Associate Director, Biostatistics role. Highlight your statistical expertise and leadership in drug development to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about biostatistics and how your experience aligns with our needs. Be sure to mention any innovative methodologies you've used.
Showcase Your Communication Skills:Since strong communication is key for this role, make sure your application materials are clear and concise. We want to see how you can effectively convey complex statistical concepts to various stakeholders.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at CSL Plasma Inc.
✨Know Your Stats
Brush up on your statistical methodologies and be ready to discuss how you've applied them in past projects. Be prepared to explain your thought process behind study designs and data analyses, as this will show your depth of knowledge and experience.
✨Understand the Regulatory Landscape
Familiarise yourself with the regulatory authorities you'll be interacting with, like the FDA or EMA. Knowing their guidelines and expectations can help you articulate how your statistical strategies align with regulatory requirements during the interview.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership in biostatistics, especially in cross-functional teams. Discuss how you've influenced clinical development plans and contributed to governance reviews, as this demonstrates your ability to lead and collaborate effectively.
✨Communicate Clearly
Practice explaining complex statistical concepts in simple terms. Since you'll be communicating with stakeholders who may not have a deep understanding of biostatistics, being able to convey your ideas clearly will set you apart and show your strong interpersonal skills.
